The main objective of this study is to investigate the safety, pharmacokinetics (PK) and the relationship between PK and pharmacodynamics (Minimum Inhibitory Concentration [MIC] and Mutant Prevention Concentration [MPC]) of intravenous BAYQ3939 (400 mg BID and 400 mg TID) in hospitalized patients with bacterial pneumonia or secondary infection of chronic respiratory disease with severe disease or a poor response to other antimicrobials. In addition, the efficacy of the ciprofloxacin, in terms of clinical response and microbiological response, will be investigated, but as a secondary endpoint.

A Prospective, Non-randomized, Open-label, Non-controlled, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics/ Pharmacodynamics of BAYQ3939 (400 mg BID and TID) in Hospitalized Patients With Bacterial Pneumonia or Secondary Infection of Chronic Respiratory Disease With Severe Disease or a Poor Response to Other Antimicrobials

Cmax/MPC [ Time Frame: Within 0-24 hours and 48-72 hours after the first study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical response rate based on resolution of signs and symptoms [ Time Frame: Up to 13 days after the first study drug administration ] [ Designated as safety issue: No ]

Microbiological response rate, assessed as eradication rate based on microbiologically evaluable patients [ Time Frame: Up to 23 days after the first study drug administration ] [ Designated as safety issue: No ]

Test of cure rate based on resolution of signs, symptoms, and the clinical response [ Time Frame: Up to 23 days after the first study drug administration ] [ Designated as safety issue: No ]

2) Hospital-acquired pneumonia (HAP): For the patient with Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1hours for 7 to 14 days For the patient with 30 ≤Ccr ≤60 mL/min, 400 mg BID, i.e. every 12 ± 1hours for 7 to 14 days 3) Secondary infection of chronic respiratory disease 400 mg BID, i.e. every 12 ± 1 hours (For those with of Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.

Eligibility

Ages Eligible for Study:

20 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Males and non-pregnant, non-lactating females with written informed consent, 20 years of age or older.

Within 48 hours prior to the first study drug administration, all patients should have the pathogens identified with appropriate specimens (e.g., sputum, tracheal aspirate, bronchoalveolar lavage [BAL], protected brushing specimen [PBS]), or should have appropriate specimens highly likely to identify the pathogens sampled. (However, the patients with Legionellosis is enrolled when the test of Legionella antigen is positive.)

The following severe bacterial pneumonia meeting the diagnostic criteria of pneumonia or secondary infection of chronic respiratory disease

Severe pneumonia

Community-acquired pneumonia: PORT score III, IV or V

Hospital-acquired pneumonia [HAP]-Group B and with a low risk for multidrug-resistant pathogens

Patients with [HAP]-Group A whose pathogen is suspected to be Pseudomonas aeruginosa

Hospitalized patients with bacterial pneumonia with a poor response to other antimicrobials Note: The patients should be limited to CAP patients with PORT score III, IV or V and HAP patients with-Group A or B who don't respond to or have a poor response to other antimicrobials over 3day's treatment.2

Secondary infection of chronic respiratory disease

Patients who are hospitalized for the treatment of secondary infection of chronic respiratory disease

Hospitalized patients with secondary infection of chronic respiratory disease with a poor response to other antimicrobials Note: The patients should be limited to secondary infection of chronic respiratory disease patients who don't respond to or have a poor response to other antimicrobials over 3day's treatment.

Exclusion Criteria:

Creatinine clearance (Ccr) ≤ 30 mL/min or nephrotic syndrome

Patient with chronic treatment of immunosuppressive drug

Decompensated congestive heart failure

Subject who received more than 24 hours of an antibacterial drug for the current infection

Patient who requires Intensive Care Unit (ICU) management [In case subjects who don't correspond to the severity for ICU management need to be admitted to ICU due to a circumstance of the site (e.g. shortage of hospital beds), those subjects shall not be excluded]

Patients with infections other than pneumonia or secondary infection of chronic pulmonary disease

Lung abscess, or empyema

Viral, fungal, mycobacterial, or atypical pneumonia as a primary diagnosis

Known or suspected bacteremia secondary to Staphylococcus aureus

Known causative microorganisms other than indication (microorganisms) of the study drug, or positive in urinary antigen test of Streptococcus pneumonia

Infection that necessitates the use of a concomitant antibacterial agent in addition to study medication [excluding subjects with concomitant use of long-term, low-dose macrolide for chronic respiratory diseases, sulbactam sodium/ampicillin sodium (Unasyn-S) and clindamycin (Dalacin-S)]

Known bronchial obstruction or a history of post-obstructive pneumonia

Known primary lung cancer

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561794